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FDA 510(k)

NeuroQ 3.8

K-Number: K180077 · 2018-08-16

ApplicantSyntermed
Decision Date2018-08-16
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NeuroQ 3.8 is a medical device manufactured by Syntermed. It received FDA 510(k) clearance on 2018-08-16 under approval number K180077. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroQ 3.8?

NeuroQ 3.8 is a medical device that received FDA 510(k) clearance on 2018-08-16. It is manufactured by Syntermed. The 510(k) number is K180077.

When was NeuroQ 3.8 approved by the FDA?

NeuroQ 3.8 received FDA 510(k) clearance on 2018-08-16, under approval number K180077.

What company makes NeuroQ 3.8?

NeuroQ 3.8 is manufactured by Syntermed.

What is the FDA product code for NeuroQ 3.8?

The FDA product code for NeuroQ 3.8 is KPS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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